Charities criticised the move saying it left many patients with very few options of effective pain relief.

Suicide risk

The MHRA is sending letters to GPs informing them of the decision.

Data shows fatal overdoses due to co-proxamol are the second most frequent means of suicide with prescribed drugs in England and Wales, accounting for up to 400 deaths each year.

The risk of death associated with co-proxamol overdose seems to be higher than for either tricyclic antidepressants or paracetamol.

The drug is a combination analgesic containing paracetamol and the opioid dextropropoxyphene and is available only with a prescription.

But some say co-proxamol is no better than full strength paracetamol at relieving pain and is known to be very toxic in overdose.

For this reason, the Committee on Safety of Medicines, an independent expert body that advises the government on medicines, was asked to look at the risks and benefits of co-proxamol.

Bad news

Measures have already been taken to address concerns about the medicine, including making advice more prominent on the packaging.

But they have failed to reduce the number of fatalities, according to experts.

Chairman of the CSM Professor Gordon Duff said: "Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative.

"There is no need for panic or concern and if patients have been taking co-proxamol continuously for a long time they should not stop without consulting their doctor."

Neil Betteridge, of Arthritis Care, said the move was bad news for people with arthritis, particularly given the recent safety concerns about other painkillers such as COX-2 inhibitors.

"The withdrawal of co-proxamol leaves many people with very few options for the safe and effective management of their pain.

"Although we understand the MHRA's concern, we are of the view that a stringent package of prescribing advice, packaging changes and other warnings should limit the risks of co-proxamol being misused," he said.

A spokeswoman from the Arthritis Research Campaign said: "Co-proxamol is a very effective and much safer than some of the other painkillers.

"It's incredibly bad news."

It is estimated that 1.7 million GP patients per year receive 7.5 million prescriptions for co-proxamol. ]]>Suicide Painkiller Withdrawnhttp://www.yourlawyer.com/articles/title/suicide-painkiller-withdrawn-1
Mon, 31 Jan 2005 00:00:00 -0500http://www.yourlawyer.com/articles/title/suicide-painkiller-withdrawn-1Co-proxamol, prescribed to hundreds of thousands of Britons every year, is to be the subject of a staggered withdrawal because of evidence that it can cause death if patients exceed the maximum recommended dosage by as little as two tablets.

Up to 400 deaths a year are linked to either accidental or intentional overdoses of co-proxamol, which is normally taken for mild to moderate pain and is similar to paracetamol. A recent study found that the medication, whose effects are increased by alcohol, was responsible for 18 per cent of all drug-related deaths and 5 per cent of all suicides. David Kelly, the Government’s weapons adviser, is believed to have taken up to three packets of co-proxamol shortly before his death in 2003.

Last year eight million prescriptions were issued in England and Wales for co-proxamol, which has been a mainstay in British healthcare for more than 40 years.

As recently as 1997 it was the second most prescribed drug, after the antibiotic amoxycilin. It is currently marketed by several pharmaceutical companies as co-proxamol and it is also sold under the brand names Distalgesic, Cosalgesic and Dolgesic.

A number of pharmaceutical giants including Eli Lilly, which produced Distalgesic through its subsidiary company Dista, will be affected by the announcement, which will signal the end of a market worth tens of millions of pounds. However, as the patent on co-proxamol has expired and it is now produced in many cheap generic forms, no single company is likely to suffer crippling financial losses.

Patients on co-proxamol, which is used to treat conditions such as mild back pain and arthitis, are recommended not to take more than eight tablets over a 24-hour period. But the ingestion of as few as ten tablets has been linked to overdose and death, often caused by slowing of the respiratory system, abnormal heart rhythms and cardiac arrest.

Co-proxamol is a combination of paracetamol and dextropropoxyphene (DXP), a narcotic related to methadone. Studies have shown that while it is no more effective as pain relief than paracetamol, the odds of dying after a co-proxamol overdose are 28 times higher.

The Times understands that an announcement on the withdrawal of co-proxamol will be made tomorrow by the Medicines and Healthcare products Regulatory Agency (MHRA), the drugs regulator. It has been the subject of an MHRA risk and benefit review since last June. The MHRA is expected to advise that doctors no longer initiate new prescriptions of the drug. Those patients taking co-proxamol should not stop taking it without consulting their doctor. Instead, the MHRA is likely to advise that they should have their prescription changed at their next doctor’s appointment.

While the withdrawal is likely to encounter opposition from some doctors whose patients have enjoyed the benefits of co-proxamol for many years, the MHRA’s decisive move will have strong support from health professionals concerned at the unnecessary risk.

The action is the latest to be taken against high-profile medicines in recent months, after the withdrawal of the antiarthritis drug Vioxx, which had been shown to double the risk of heart attack and stroke.]]>MHRA Withdraws the Pain Killer Co-Proxamolhttp://www.yourlawyer.com/articles/title/mhra-withdraws-the-pain-killer-co-proxamol
Mon, 31 Jan 2005 00:00:00 -0500http://www.yourlawyer.com/articles/title/mhra-withdraws-the-pain-killer-co-proxamolA recent consultation looking at evidence for the safety and effectiveness of co-proxamol found that the benefits of the medicine did not outweigh the risks and that it should be gradually withdrawn from clinical use. Co-proxamol is associated with 300-400 intentional and accidental fatal overdoses each year.

The Chairman of the Committee on Safety of Medicines (CSM), Professor Gordon Duff said:

"Co-proxamol will be phased out of the market place gradually to give patients time to discuss their treatment with their doctor and change to a suitable alternative. There is no need for panic or concern and if patients have been taking co-proxamol continuously for a long time they should not stop without consulting their doctor.”

"Whilst the risks of co-proxamol are well known to health professionals, the latest evidence is that the measures to strengthen the labelling of co-proxamol have been ineffective in reducing the high fatality rate involving both intentional and accidental overdose. The MHRA and CSM have considered further evidence gathered during a public request for information on the risks and benefits of co-proxamol and have decided that the benefits of the continued availability of co-proxamol do not outweigh the risks and that co-proxamol should be withdrawn from the market.”

Co-proxamol is available only on prescription and contains a combination of paracetamol and dextropropoxyphene. It is estimated that 1.7 million GP patients per year receive 7.5 million prescriptions for co-proxamol.]]> Seizures Linked To Popular Painkillerhttp://www.yourlawyer.com/articles/title/-seizures-linked-to-popular-painkiller
Mon, 03 Jan 2005 00:00:00 -0500http://www.yourlawyer.com/articles/title/-seizures-linked-to-popular-painkillerWhile the drug has regularly appeared in adverse drug-reaction bulletins in Australia, US medical studies have previously declared the painkiller to carry only a low risk of causing seizures.

The latest drug scare follows another report, in the British Medical Journal, that US drug giant Eli Lilly suppressed evidence that anti-depressant Prozac could cause behavioural disturbances.

Melbourne seizure specialist Samuel Berkovic said yesterday medical specialists had noticed an increasing number of fits in patients who had taken tramadol.

Previously, medical experts had raised concerns over patients with pre-existing epilepsy conditions and the taking of tramadol in combination with anti-depressants.

"We cannot calculate the exposure risk in our population, but the frequency of tramadol-related seizures suggests that they may be under-reported," Dr Berkovic wrote in a letter to the Medical Journal of Australia published yesterday. "Of 97 patients with confirmed seizures (observed in 2003-04), eight were associated with tramadol.

"Two patients who had received high doses of tramadol had developed seizures within 24 to 48 hours.

"No patient had a prior history of seizures and none had a recurrence after they had ceased taking tramadol for a median of nine months follow-up."

Since tramadol was first marketed in Australia in the late 1990s its use has increased dramatically, with reports of 726 adverse events and 1922 reactions to the Australian Adverse Drug Reaction Advisory Committee.

The committee had received 66 reports involving tramadol users suffering convulsions and in 27 cases tramadol was the sole suspected drug.

Last month, the New York Medical Examiner's Office determined that international rapper Ol' Dirty Bastard died from a fatal combination of cocaine and tramadol after he collapsed and suffered a heart attack.

With 1.65 million tramadol prescriptions issued in Australia last year, doctors should always consider tramadol as a possible cause when patients presented with unexplained seizures, Dr Berkovic said.

Otherwise, he warned, they risked wrongly diagnosing the patient with epilepsy.

Other effects commonly reported to medical authorities include nausea, vomiting, dizziness and confusion.

Concerns have also been heightened over adverse drug reactions to the top-selling anti-depressant Prozac.

Confidential Lilly documents and memos provided to the BMJ suggest executives were aware of troubling side-effects in the 1980s.]]>Ultracet Side Effects Lawsuits | Side Effects: Seizures, Head Trauma, Metabolic Disordershttp://www.yourlawyer.com/topics/overview/ultracet
Mon, 03 Jan 2005 00:00:00 -0500http://www.yourlawyer.com/topics/overview/ultracet WE ARE PRESENTLY NOT TAKING ANY MORE CASES.

WE ARE PRESENTLY NOT TAKING ANY MORE CASES.

Ultracet Side Effects May Lead To Seizure Lawsuits

Ultracet (Generic Name: Tramadol/Acetominophen) is a pain medication that combines tramadol, a leading prescription pain reliever, and acetaminophen, the most commonly recommended over-the-counter analgesic in the U.S.(Tylenol). Doctors recently warned that one of the nation's most commonly prescribed painkillers, Ultracet (tramadol//acetominophen), has been linked to a growing number of seizures among patients.

The drug has regularly appeared in adverse drug-reaction bulletins in Australia, US medical studies have previously declared the painkiller to carry only a low risk of causing seizures.

Melbourne seizure specialist Samuel Berkovic said yesterday medical specialists had noticed an increasing number of fits in patients who had taken Ultracet(tramadol/acetominophen). Previously, medical experts had raised concerns over patients with pre-existing epilepsy conditions and the taking of Ultracet (tramadol/acetominophen) in combination with anti-depressants.

We cannot calculate the exposure risk in our population, but the frequency of tramadol-related seizures suggests that they may be under-reported," Dr Berkovic wrote in a letter to the Medical Journal of Australia published yesterday. Of 97 patients with confirmed seizures (observed in 2003-04), 8 were associated with tramadol.

Two patients who had received high doses of tramadol had developed seizures within 24 to 48 hours. "No patient had a prior history of seizures and none had a recurrence after they had ceased taking tramadol for a median of nine months follow-up.

Seizures have been reported in patients receiving tramadol. The risk of seizures is increased with doses of tramadol above the recommended range. Tramadol increases the seizure risk in patients taking certain medications (e.g., tricyclic antidepressants, selective serotonin reuptake inhibitors, opioids) and may enhance the seizure risk in patients taking MAO inhibitors, neuroleptics, or other drugs that reduce the seizure threshold or in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and CNS infections).

Legal Help For Victims Affected By Ultracet

If you or a loved one were affected by Ultracet, please fill out the form at the right for a free case evaluation by a qualified attorney or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).